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Orso v. Bayer Corp.

September 27, 2006


The opinion of the court was delivered by: Judge Joan B. Gottschall


Plaintiff Kathi Urso*fn1 ( "Urso") has filed a four-count amended complaint against defendant Bayer Corporation ("Bayer") for herself individually and on behalf of a putative nationwide class of fellow plaintiffs. This court's jurisdiction is based on diversity.*fn2 Before the court are Bayer's motion to dismiss the amended complaint, motion to strike exhibits and portions of pleadings, and motion for sanctions. For the reasons set forth herein, the motion to dismiss is granted in part and denied in part, the motion to strike is denied as moot, and the motion for sanctions is denied.


Urso alleges that she suffered injuries from using Neo-Synephrine, an over-the-counter nasal decongestant manufactured by Bayer. Bayer has manufactured and distributed NeoSynephrine for decades, first as a prescription medication, and more recently as an over-the-counter medication. Neo-Synephrine's packaging warns potential users not to exceed the recommended dosage, not to use for more than three days, and to "stop use and ask a doctor if symptoms persist for more than 3 days." Customers are cautioned that if they use NeoSynephrine for longer than the recommended time period, nasal congestion may recur or worsen. Urso claims that she used Neo-Synephrine exactly as directed and became permanently addicted to it. She currently suffers from rhinitis medicamentosa, allegedly brought on by using NeoSynephrine, and cannot breathe without the use of a topical nasal decongestant. Her complaint seeks monetary and injunctive relief against Bayer for herself and on behalf of all of the individuals in the putative class.

When Bayer manufactured and distributed Neo-Synephrine as a prescription medication in the past, it provided physicians with information about Neo-Synephrine's potentially dangerous side effects as required by law. Once Bayer obtained approval to sell Neo-Synephrine as an over-the-counter medication, the Food and Drug Administration ("FDA") no longer required it to inform physicians directly of any new risks or contraindications associated with Neo-Synephrine. Instead, Bayer was required to put certain instructions and warnings on the label of the product and was also required to file certain information, including results of its studies relating to Neo-Synephrine, with the FDA on a periodic basis. Currently, there is no legal requirement that drug manufacturers, including Bayer, provide the detailed information supplied to the FDA to physicians or the public directly.

In her original complaint, Urso pleaded claims in strict liability, negligence, consumer fraud, and deceptive trade practices. Although Bayer moved to dismiss all of the causes of action, Urso's complaint survived Bayer's motion nearly intact. This court concluded that only the failure to warn component of her products liability counts did not state a claim upon which relief could be granted, given the Seventh Circuit's recent holding in Kelso v. Bayer Corp., 398 F.3d 640, 642 (7th Cir. 2005) (holding Bayer's warnings on Neo-Synephrine's packaging are adequate as a matter of law). The remainder of her products liability claim, as well as the other three counts, were allowed to stand. Minute Order (March 8, 2005). Urso nevertheless moved for leave to amend her complaint and filed her amended complaint on July 27, 2005.

Urso's amended complaint is substantially similar to her original complaint. In both, she set out four counts alleging strict products liability, negligence, consumer fraud, and deceptive trade practices. The two principal differences are Neo-Synephrine's alleged design defect and the failure to warn claim, both of which had other incarnations in the original complaint. With respect to the design defect, Urso has alleged that Neo-Synephrine contains a dangerous neurotransmitter in its formula (as opposed to the allegedly dangerous combination of two ingredients pleaded in the original complaint). Since the court dismissed her original failure to warn claim in its previous ruling, Urso's amended complaint advances a novel legal theory: that Bayer's instruction to "ask a doctor" if symptoms persist beyond three days on NeoSynephrine's label gives rise to a duty to warn physicians directly, presumably so the physicians can pass these warnings along to their patients when consulted in accordance with the labeling. Urso claims that physicians, including her own, are currently unable to obtain information about Neo-Synephrine's risks and side effects in the absence of such disclosure and distribution, and argues that the burdens of distributing this information are not great and are outweighed by both the helpfulness of and the need for the information.

Not surprisingly, Bayer has denied the existence of this duty. Instead, it states that its warnings on Neo-Synephrine are adequate as a matter of law. It further asserts that NeoSynephrine's warning to "ask a doctor" is not a voluntary undertaking giving rise to an additional duty to warn since it was mandated by the FDA and was given pursuant to law and not gratuitously. Indeed, Bayer argues that its only duty to warn is to the ultimate user -- the consumer -- and that the learned intermediary doctrine, which imposes a duty on drug manufacturers to educate physicians on the risks of prescription drugs, does not apply to over-the-counter medication. Bayer also addresses the remainder of Urso's complaint, arguing that the allegations are insufficient to state a claim in strict products liability or negligence (Counts I and II), and that Counts II, III and IV (negligence, consumer fraud, and deceptive practices) are preempted by the Food and Drug Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296, and by the preemption provisions contained in each of the state statutes.


A. Motion to Dismiss

In reviewing a motion to dismiss for failure to state a claim under Rule 12(b)(6), the court reviews all facts alleged in the complaint and any reasonable inferences drawn from those facts in the light most favorable to the plaintiff. Marshall-Mosby v. Corporate Receivables, Inc., 205 F.3d 323, 326 (7th Cir. 2000). The court will grant the motion only if it appears that the plaintiff cannot prove any set of facts that would entitle her to relief. Conley v. Gibson, 355 U.S. 41, 45-46 (1957).

1. Strict Products Liability and Negligence (Counts I and II)

The first two counts of Urso's complaint are common law tort claims alleging strict liability and negligence arising from Bayer's manufacture, distribution, marketing and labeling of Neo-Synephrine. Urso did not designate a specific products liability theory of recovery in her complaint. Products liability actions traditionally encompass three types of actionable claims: design defect, manufacturing defect, and failure to warn. Sollami v. Eaton, 772 N.E. 2d 215 (Ill. 2002). As this court previously held when addressing Bayer's first motion to dismiss, Urso's failure to warn claim, both in strict liability and in negligence, is barred as a matter of law by the Seventh Circuit's holding inKelso v. Bayer Corp.,398 F.3d 640 (7th Cir. 2005). In Kelso, the plaintiff misused Neo-Synephrine due to a perceived ambiguity in the product's labeling and claimed that Bayer should be strictly liable for his damages under a failure to warn theory. Id. at 641. The Seventh Circuit rejected his argument and affirmed summary judgment for Bayer, holding that Neo-Synephrine's warnings on its packaging were adequate as a matter of law. Id. at 643. Since the Seventh Circuit has spoken definitively on the adequacy of Neo-Synephrine's labeling, this court was, and still is, bound by its holding here.

In her amended complaint, Urso attempts to circumvent Kelso. Because Bayer advises consumers to see a doctor if symptoms persist, Urso argues that it has a duty to warn physicians in addition to its duty to warn consumers and end users.*fn3 According to Urso, along with posting a warning on boxes of Neo-Synephrine, Bayer should be required to notify physicians of the dangers of its over-the-counter products or, in the alternative, disclose that it is not advising physicians about Neo-Synephrine's dangers on its labeling. In support of this duty, she points out that Neo-Synephrine was once available only by prescription, during which time Bayer was required by law to notify physicians about its side effects, and that imposing such a duty to warn upon Bayer would be fair. Bayer is already required to submit adverse drug experience information about Neo-Synephrine to the FDA and could send that same information to physicians. Urso argues that because Bayer has communicated directly with physicians in the past, when Neo-Synephrine was a prescription drug, doing so now would not impose an onerous burden. In ...

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